Analytical support for drug discovery and early drug candidate developement.

Summary: Analytical laboratory support for QC, R&D, and manufacturing. Focus on test method development and improvement for raw materials and final product. Laboratory manager for R&D and QC labs with emphasis on laboratory improvement projects and regulatory compliance projects. Perform all QC final product release testing.Laboratory analytical lead for product development of polymer based Class III medical deviceso Instruments: GPC, HPLC, titration, rheology, FTIR, UV-Vis, and Instrono Developed titration methods for raw material and in-process product analysis for viscous sample in non-aqueous water sensitive environmento Researched novel chemical and physical properties of unique polymer systemso Support pilot scale manufacturing studies of clinical trial product to improve manufacturing process robustnesso Execute R&D pilot and bench scale formulations for DOE studiesGMP test method developmento Developed HPLC integration method for QC product release to improve compliance and improve analysis timeo Burst pressure and appearance QC release test method validation to support FDA responseQuality Investigations and Supporto Technical lead for software validation program to support ISO 13485 and 21CFR11o Applied risk based approach matrix to drive software validationso Validated all current laboratory software systems and implemented process for future systemso Managed 10 CAPAs and NCRs for QC and R&D laboratoriesQC Product Release – Class IIIo Responsible for all in-process and final product QC release testingQC and R&D Lab Managero Calibration and preventative maintenance coordinatoro Lead implementation of online calibration and preventative maintenance tracking systemo Lead all out of tolerance investigations and supporting documentationo Statistical software: MiniTab and Microsoft Excelo Student Co-op program supporto Recruiting, interviewing, and hiring process lead

Summary: Work in both R&D and QC group to research, develop, and implement product improvements and test methods for novel polymers. Working with novel synthetic polymers and innovative medical devices in a fast paced small company environment.R&D and QC Test Method Development and Validation - Analytical lead for product development studies and investigationsQuality Control Product Release Testing - Responsible for all final product release testing per CoAR&D Studies to Support Manufacturing - Investigation of raw material and in-process testing methods to improve manufacturing controlR&D and QC Laboratory Manager

Studied forced degradation studies on a broad range of pharmaceutical products to comply with a new regulatory requirement.

Summary: Analytical and product support for immuno-hematology product lines. Focus on existing process and product optimization. Included technology transfer to manufacturing and quality as well as validation of projects.Manufacturing process optimization and development in cGMP lab environmento Reformulated an approved product to eliminate protein/polymer precipitateo Implemented new manufacturing process, equipment, and documentso Utilized HPLC and viscosity to indicate improved solubility of polymer matrixo Supported transfer of improved antibody filtration method to suppliero Organized all development, validation, IQ/OQ/PQ, and training documentationLead feasibility investigation of container compatibility study for red blood cellsSupported development and validation of crude raw material additive to reduce manufacturing time and improve final product appearanceo Supported investigation of manufacturing scale o Transferred test methods to QC laboratory and lead all trainingTechnical and Lunch & Learn presentations to company audienceSix Sigma Process Excellence Yellow Belt (Certified) and Green Belt (Trained)

Research and development of new manufacturing processes and products. Method development and technical document writing. Product support for manufacturing including investigation of field failures and manufacturing process improvements.